Staska Pharmaceuticals, Inc. Initiates Nationwide Recall of Preservative-Free Ascorbic Acid Injection Solution (500mg/mL, Non-Corn) Following Detection of Glass Contaminants

Summary

Company Announcement

FOR IMMEDIATE RELEASE – 10/10/2024 – Bennet, NE, STASKA PHARMACEUTICALS, INC. is voluntarily recalling one lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. The recall is due to the detection of glass particles in one specific lot of vials utilized for this production batch.

Injecting a product with particulate matter may lead to local irritation or swelling. Such particles could potentially obstruct blood vessels in the heart, lungs, or brain, resulting in a stroke or even death. The likelihood and intensity of these adverse effects can vary based on factors such as the size and quantity of particles present, patient health conditions, and any vascular irregularities.

As of now, STASKA PHARMACEUTICALS has not been informed of any reports concerning particulate matter or adverse effects related to this recall. The risk is further minimized since the product label instructs healthcare professionals to visually inspect the product for any foreign substances or precipitate before administration.

The Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL 50mL serves as a vitamin supplement, packed in amber vials. The affected lot is SP2400058, set to expire on 12/31/2024, and was distributed to authorized healthcare providers between 07/31/2024 and 08/27/2024.

STASKA PHARMACEUTICALS prioritizes patient safety and product integrity. The company has directly notified all clients who received the product via email and telephone, and is managing the return and substitution of all recalled items. Healthcare providers should cease using, isolate, and directly contact STASKA PHARMACEUTICALS for arrangements regarding the return and replacement.

Customers with inquiries about the recall can reach STASKA PHARMACEUTICALS at 402-782-2207 or 888-801-1370 from Monday to Friday, 8 AM to 5 PM CDT. Additionally, consumers should consult their healthcare provider if they face any issues that may relate to the use of this medication.

Any adverse reactions or quality issues associated with this product may be reported to the FDA’s MedWatch Adverse Event Reporting program through various methods including online submissions, or by regular mail or fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and send it to the address listed on the pre-addressed form, or submit it via fax to 1-800-FDA-0178

This recall is being conducted with the oversight of the U.S. Food and Drug Administration.